Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01452412
Other study ID # 2009-408
Secondary ID R01DK087783
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date October 2011
Est. completion date August 2016

Study information

Verified date December 2019
Source Albert Einstein College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Kidney disease is a common medical condition. Individuals with kidney disease develop a build-up of acid in their blood. This acid can affect their muscles, bones, glucose metabolism and kidneys. The investigators will test alkali treatment, to treat acid build-up, in a randomized placebo-controlled clinical trial to evaluate effects on muscles, bones, glucose metabolism and kidney.


Recruitment information / eligibility

Status Completed
Enrollment 149
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria:

- Estimate GFR <= 45 and >15 ml/min/1.73m2

- Age >18

Exclusion Criteria:

- Previous chronic treatment with alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda)

- bicarbonate level <20 or >25 mEq/L

- New York Heart Association Class III or IV heart failure

- Systolic blood pressure >180 mmHg

- Initiation of ESRD treatment planned within 6 months

- Kidney transplantation

- Treatment with immunosuppressives within the last 3 months

Study Design


Intervention

Drug:
Sodium bicarbonate
0.4 mEq/kg/day ideal body weight to be taken once a day
Placebo
To be taken on the same schedule as the active arm

Locations

Country Name City State
United States Albert Einstein College of Medicine Bronx New York
United States Case Western Reserve University Cleveland Ohio

Sponsors (3)

Lead Sponsor Collaborator
Albert Einstein College of Medicine National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sit to Stand to Sit Speed: Time Taken to Sit to Stand to Sit 10 Times Sit to stand to sit x10 speed (time to perform sit to stand to sit 10 times) will be measured and compared between groups. 2 year
Primary DEXA of Wrist The investigators will evaluate changes in bone mineral density at the wrist. 2 year
Secondary Hand-grip Strength Hand-grip strength will be measured in all participants 2 year
Secondary Estimated GFR Estimated GFR 2 year
Secondary Quality of Life - Physical Function Domain Short Form- 36 (SF-36) will be performed in all participants. We will evaluate effects on the Physical Function Domain. The Physical Function Domain is scored from 0 to 100 with higher scores meaning better physical functioning. 2 year
See also
  Status Clinical Trial Phase
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Recruiting NCT06363097 - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Terminated NCT04043026 - The Effects of Renal Function and Atrial Fibrillation on Lipoproteins and Clot Structure/Function
Completed NCT05318014 - Low-protein Formula Supplements in Chronic Kidney Disease N/A
Active, not recruiting NCT06071065 - Clinical Pharmacist Intervention on Medication Adherence and Clinical Outcomes in Chronic Kidney Disease Patients N/A
Completed NCT02878317 - Skin Autofluorescence as a Risk Marker in People Receiving Dialysis.
Not yet recruiting NCT06039254 - Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function Phase 1
Recruiting NCT03160326 - The QUALITY Vets Project: Muscle Quality and Kidney Disease
Completed NCT02875886 - DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease Phase 4
Completed NCT02888171 - Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency N/A
Withdrawn NCT02885545 - The Strategy to Prevent Hemorrhage Associated With Anticoagulation in Renal Disease Management (STOP HARM) Trial Phase 4
Completed NCT02756520 - Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-024-CNI)
Completed NCT02896309 - The Effect of Correction of Metabolic Acidosis in CKD on Intrarenal RAS Activity N/A
Completed NCT02836574 - A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease Phase 2
Active, not recruiting NCT02483039 - Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization N/A
Completed NCT02992548 - Effect of Pravastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease Phase 4
Completed NCT02369549 - Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease Phase 3
Terminated NCT02543177 - Optimised Procedure in Patients With NSTEMI and CKD N/A
Recruiting NCT02205944 - Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes N/A
Active, not recruiting NCT02231138 - Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease Phase 4